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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K262383

510(k) cleared

LumenCare Azure

Nucletron B.V. · Jul 24, 2026 · K262383

FDA cleared the LumenCare Azure from Nucletron B.V. on Jul 24, 2026 under K262383, a special 510(k). The device falls under product code JAQ, System, Applicator, Radionuclide, Remote-Controlled, regulated at 21 CFR 892.5700 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 13, 2026. The decision came 11 days later, inside the 90 FDA-day goal for a 510(k).

Nucletron B.V. has one other decision in the tracker over the last 12 months: K251037 (Rectal Applicator).

Questions & Answers

What did FDA clear under K262383?

K262383 is the FDA 510(k) for LumenCare Azure, submitted by Nucletron B.V.. FDA's decision date was Jul 24, 2026, under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled).

Who makes the LumenCare Azure?

Nucletron B.V., based in Veenendaal, is the applicant of record for K262383.

How long did the K262383 review take?

FDA received the submission on Jul 13, 2026 and issued its decision on Jul 24, 2026, 11 days later.

← All decisions in July 2026

Sources